Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products.

Sujet

Bétail

Mot clé

Santé des animaux Médicaments Autorisation/permis Commerce intérieur Aliments pour animaux

Aire géographique

Países de la Unión Europea

Résumé

Member States shall take all appropriate measures to ensure that the particulars and documents which shall accompany applications for authorization to place a veterinary medicinal product on the market, pursuant article 5 of Directive 81/851/EC, are submitted by the persons concerned in accordance with the Annex to this Directive. The Annex is divided in 3 parts: analytical (physico-chemical, biological or microbiological) tests of veterinary medicinal products (I), toxicological and pharmacological tests (II), clinical trials (III). (4 articles and 1 Annex).

Texte intégral

Anglais

Site web

europa.eu

Références - Législation

Implementé par

Legislative Decree No. 119 implementing Directives Nos. 81/851/CEE, No. 81/852/CEE, No. 87/20/CEE and No. 90/676/CEE on veterinary drugs.

Législation | Italie | 1992 (1997)

Mot clé: Santé des animaux, Médicaments, Autorisation/permis, Commerce international

Source: FAO, FAOLEX

Veterinary medicinal products (Presentation and content of license applications forms) Regulations 2002 (P.I. 200/2002).

Législation | Chypre | 2002

Mot clé: Médicaments, Autorisation/permis, Enregistrement, Commerce international, Santé des animaux

Source: FAO, FAOLEX

Marketing Authorisations for Veterinary Medicinal Products Amendment Regulations 2000 (S.I. No. 776 of 2000).

Législation | Royaume-Uni | 2000

Mot clé: Sous-produits animaux, Inspection, Quarantaine, Parasites/maladies, Transport/dépôt, Hygiène/procédures sanitaires, Santé des animaux

Source: FAO, FAOLEX

Animal Remedies Regulations, 1996.

Législation | Irlande | 1996

Mot clé: Santé des animaux, Médicaments, Autorisation/permis, Commerce intérieur, Commerce international, Inspection

Source: FAO, FAOLEX

Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. No. 3142 of 1994).

Législation | Royaume-Uni | 1994

Mot clé: Sous-produits animaux, Inspection, Quarantaine, Parasites/maladies, Transport/dépôt, Hygiène/procédures sanitaires, Santé des animaux, Médicaments

Source: FAO, FAOLEX

Amendé par

Council Directive 93/40/EEC amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.

Législation | Union européenne | 1993

Mot clé: Médicaments, Autorisation/permis, Enregistrement, Commerce intérieur, Commerce international, Santé des animaux

Source: FAO, FAOLEX

Commission Directive 99/104/EC amending the Annex to Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products.

Législation | Union européenne | 1999

Mot clé: Santé des animaux, Médicaments

Source: FAO, FAOLEX

Abrogé par

Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products.

Législation | Union européenne | 2001

Mot clé: Législation de base, Santé des animaux, Médicaments, Autorisation/permis, Collecte de données/déclarations, Accès-à-l'information, Inspection, Commerce intérieur, Commerce international, Infractions/sanctions

Source: FAO, FAOLEX